Data Standards Monthly Project Lead 25 November 2019 Meeting Minutes

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  • Project team updates


  • Aatiya Zaidi
  • Amy Palmer
  • Bhavin Busa
  • Jane Lozano
  • Janet Low
  • Kiran Kundarapu
  • Mike Hamidi
  • Satheesh Avvaru
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Presenting Poster at the US 2020 Connect. Survey currently with Aimee and Mary with publishing on December 2nd and close on December 18. Survey to be sent to the PHUSE Community.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Presenting poster accepted for US 2020 Connect. Interactive deliverables currently with CDISC to produce. Deliverable pushed out to Q12020.
Data Reviewer's Guide in XML Mike Hamidi Updated package ready to be uploaded to the PhUSE website. Webinar on December 11th. Jane to present at the webinar as Mike is not available.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin White paper is drafted and team is reviewing. Next meeting December 9th. Possible collaboration with Real World Evidence project (Emerging Trends & Technologies Working Group).
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo White Paper currently being rewritten as a second white paper is being written. Will present at the US Connect 2020. The second one is FDA and PMDA Study Data Submission Distinctions. Kiran has a poster for the FDA and PMDA study data distinctions.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Team agreed to meet bi-weekly. The template name is ciDRG (Clinial Integrated Reviewers Guide). Going to start with one template and then if it appears that two are needed, one will be created for tabulation data and one for analysis data. Initial draft of the template to be created by Kiran and Satheesh. Template will be on Teamworks site for project members to edit and comment. Need to work with SDTM ADaM Implementation FAQ regarding the white paper that group is creating. Satheesh to draft the collaboration form (to get support from FDA). To be completed next year and shared with FDA via email to Isaac and his team. First meeting scheduled for end of January 2020.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi Adjudication white paper is with proofreader and should be published within the next week. ISS/ISE white paper incorporating comments from Working Group Leads. Wanted input and opinion from PMDA and what is considered to be legacy as the white paper wants to address FDA and PMDA. Can send back to Jane and Janet in December. Next Steering Committee meeting is December 13. Team continuing to get questions. Members of ADA project (non-clinical) for immunogenicity in SDTM and ADaM want to possibly collaborate with this team. Amy is the SME or someone within CDISC.

Action Items

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